Integrated mechanical handle with quick slide mechanism

ABSTRACT

A method of deploying a prosthesis includes engaging a hub assembly of a handle to a threaded outer surface of a slide shaft of the handle; rotating the hub assembly to cause axial translation of the hub assembly and a sheath coupled to the hub assembly to initiate deployment of the prosthesis; disengaging the hub assembly from the threaded outer surface by pivoting a thread tooth of the hub assembly out of threaded engagement with the threaded outer surface; and sliding the hub assembly on the slide shaft to further retract the sheath and complete deployment of the prosthesis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. patent application Ser. No.10/752,237, filed on Jan. 5, 2004, now U.S. Pat. No. 7,105,016, issuedSep. 12, 2006, which is a Continuation-in-part of U.S. patentapplication Ser. No. 10/128,956, filed on Apr. 23, 2002, now U.S. Pat.No. 6,911,039, issued Jun. 28, 2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an intra-vascular device and method.More particularly, the present invention relates to a delivery systemfor deploying endoluminal prostheses within the lumens of the body andto a method of using the same.

2. Description of the Related Art

Vascular aneurysms were the result of abnormal dilation of a bloodvessel, usually resulting from disease and/or genetic predisposition,which weakened the arterial wall and allowed it to expand. Whileaneurysms could occur in any blood vessel, most occurred in the aortaand peripheral arteries, with the majority of aortic aneurysms occurringin the abdominal aorta, usually beginning below the renal arteries andoften extending into one or both of the iliac arteries.

Aortic aneurysms were commonly treated in open surgical procedures wherethe diseased vessel segment was bypassed and repaired with an artificialvascular graft. While considered to be an effective surgical technique,particularly considering the alternative of a usual fatal rupturedabdominal aortic aneurysm, conventional vascular graft surgery sufferedfrom a number of disadvantages. The surgical procedure was complex andrequired experienced surgeons and well-equipped surgical facilities.Even with the best surgeons and equipment, however, patients beingtreated frequently were elderly and weakened from cardiovascular andother diseases, reducing the number of eligible patients.

Even for eligible patients prior to rupture, conventional aneurysmrepair had a relatively high mortality rate, usually from 2% to 10%.Morbidity related to the conventional surgery includes myocardialinfarction, renal failure, impotence, paralysis, and other conditions.Additionally, even with successful surgery, recovery took several weeks,and often required a lengthy hospital stay.

In order to overcome some or all of these drawbacks, endovascularprosthesis placement for the treatment of aneurysms has been used.Although very promising, many of the proposed methods and apparatussuffered from undesirable limitations. In particular, accurate deliveryand placement of the endovascular prosthesis within the vasculature wasproblematic.

Stent-grafts (endovascular prosthesis) were resilient structures,usually biased to expand against the surrounding lumenal wall. Suchresiliently-expanding stent-grafts were tightly compressed within thecatheter, imposing significant radial expansion forces against thesurrounding catheter sheath. This often lead to excess friction betweenthe stent-graft and the sheath, particularly when theresiliently-expanding structure invaginated into the catheter material.Thus, the delivery system had to be capable of imparting a significant,yet controlled, force to retract the sheath and deploy the stent-grafts.

SUMMARY OF THE INVENTION

An embodiment according to the present invention includes, a method ofdeploying a prosthesis having the step of restraining the prosthesiswithin a proximal end of a sheath. A slide ring of a handle engaged withthreads in the handle is rotated in a first direction to initiate aforce for the retraction of the sheath. The slide ring is slid tocomplete retraction of the sheath and deploy the prosthesis.

As a result, a proximal end of the prosthesis, which is deployed first,is very gradually released by rotating the slide ring. In this manner,the physician is allowed to verify the accuracy of the deploymentposition as the prosthesis initially engages the surrounding body lumen.

However, since dynamic frictional forces are typically lower than staticfrictional forces, the frictional resistance, due to the forces betweenthe prosthesis and the sheath, decreases once the sheath begins to move.Additionally, as the sheath moves (retracts), more and more of theprosthesis is exposed by the sheath. For this additional reason, thefrictional resistance, due to the force between the prosthesis and thesheath, decreases once the sheath begins to move. Further, once theproximal end of the prosthesis has firmly engaged the surrounding bodylumen, the relationship between the prosthesis and the surrounding bodylumen is largely set, so that deployment can proceed safely and at amore rapid rate.

Thus, after retraction of the sheath is initiated by axial rotation ofthe slide ring, which moves axially because of the engagement ofthreaded pieces, the sheath is further retracted by sliding (manualpulling) of the slide ring. By sliding the slide ring, the sheath iseasily and quickly retracted thus rapidly completing deployment of theprosthesis. Rapid deployment of the prosthesis facilitates fasterprocedure times, thus minimizing the period of time during which bloodflow is occluded.

In accordance with another embodiment according to the presentinvention, a delivery system includes a handle and a sheath slidably andthreadedly coupled to the handle.

In yet another embodiment according to the present invention, a deliverysystem includes a handle having: a slide shaft having at least one slot;a slide ring; a slide threadedly attached to the slide ring, the slidehaving: an inner body inside the slide shaft; an outer body outside theslide shaft; and a coupler coupling the inner body to the outer bodythrough the at least one slot, wherein the slide ring and the slide areslidably mounted to the slide shaft.

In another embodiment, a delivery system includes: a sheath having apushrod lumen; a pushrod extending through the sheath; and a handlehaving a hub assembly coupled to the sheath, the hub assembly having aselectively engaging member for selectively engaging and disengaging thehub assembly from the pushrod.

In another embodiment, a delivery system includes: a sheath and ahandle. The handle includes: a slide shaft having a threaded outersurface; and a hub assembly coupled to the sheath. The hub assemblyincludes an internal slider subassembly for selectively engaging anddisengaging the hub assembly with the threaded outer surface.

In another embodiment, a delivery system includes a sheath and a handle.The handle includes: a slide shaft having a threaded outer surface; anda hub assembly coupled to the sheath. The hub assembly includes: aninner slider having a thread tooth pivot support; a thread toothpivotably mounted to the thread tooth pivot support; and a sleeve havinga thread tooth press member pressing on the thread tooth, where motionof the sleeve relative to the inner slider pivots the thread tooth onthe thread tooth pivot support to engage and disengage the hub assemblywith the threaded outer surface.

In yet another embodiment, a method includes: engaging a hub assembly ofa handle to a threaded outer surface of a slide shaft of the handle;rotating the hub assembly to cause axial translation of the hub assemblyand a sheath coupled to the hub assembly; disengaging the hub assemblyfrom the threaded outer surface by pivoting a thread tooth of the hubassembly out of threaded engagement with the threaded outer surface; andsliding the hub assembly on the slide shaft to further retract thesheath.

Embodiments according to the present invention are best understood byreference to the following detailed description when read in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a delivery system for deploying aprosthesis in one embodiment according to the present invention;

FIG. 2 is a close up partial cutaway view of a handle of FIG. 1 beforeretraction of a sheath;

FIGS. 3 and 4 are close up partial cutaway views of the handle of FIG. 2during retraction of the sheath;

FIG. 5 is a partial cross-sectional view of the handle taken at V-V ofFIG. 2;

FIG. 6 is a cross-sectional view of the handle taken at VI-VI of FIG. 5;

FIG. 7 is a close up partial cutaway view of the handle of FIG. 1 beforeretraction of the sheath in another embodiment according to the presentinvention;

FIG. 8 is a close up partial cutaway view of the handle of FIG. 7 duringretraction of the sheath;

FIG. 9 is a cross-sectional view of the handle of FIG. 7 taken at IX-IX;

FIG. 10 is a cross-sectional view of the handle taken at X-X of FIG. 9;

FIG. 11 is a cross-sectional view of the handle taken at XI-XI of FIG.8;

FIG. 12 is a cross-sectional view of the handle taken at XII-XII of FIG.11;

FIG. 13 is an enlarged cross-sectional view of region XIII of a pushrodof FIG. 11;

FIGS. 14 and 15 are perspective and side views of another embodimentaccording to the present invention;

FIG. 16 is a side view, partially in cross-section, of the deliverysystem of FIGS. 14 and 15 after retraction of a sheath;

FIG. 17 is an enlarged side view, partially in cross-section, of theregion XVII of the handle of FIG. 16;

FIGS. 18, 19 and 20 are side, top and exploded views of an internalslider subassembly;

FIG. 21 is a cross-sectional and partially cutaway view of the handlealong the line XXI-XXI of FIG. 18 with a hub assembly engaged with athreaded outer surface of a slide shaft;

FIG. 22 is a cross-sectional view of the handle of FIG. 21 with the gearteeth engagement of the hub assembly disengaged from the threaded outersurface of the slide shaft;

FIGS. 23 and 24 are exploded and side views, respectively, of a graftcover subassembly and RO marker of the delivery system of FIG. 14; and

FIGS. 25 and 26 are exploded and side views, respectively, of a strainrelief subassembly of the delivery system of FIG. 14.

Common reference numerals are used throughout the drawings and detaileddescription to indicate like elements.

DETAILED DESCRIPTION

In one embodiment, a method of deploying a prosthesis 102 (FIG. 1)includes restraining prosthesis 102 within a distal end 120 of a sheath106. A slide ring 124 of a handle 112 is rotated in a first direction asindicated by an arrow 126 (FIG. 2) to initiate retraction of sheath 106.Slide ring 124 is slid (FIGS. 3, 4) to complete retraction of sheath 106and deploy prosthesis 102 (FIG. 1).

In this manner, prosthesis 102 is initially very gradually released byrotating slide ring 124. This allows the physician to verify theaccuracy of the deployment position as prosthesis 102 initially engagesthe surrounding body lumen.

However, after retraction of sheath 106 is initiated by rotation ofslide ring 124 with respect to handle 112, retraction of sheath 106 iscompleted by sliding of slide ring 124 along the longitudinal axis ofhandle 112. In this manner, sheath 106 is easily and quickly retractedthus rapidly completing deployment of prosthesis 102. Rapid deploymentof prosthesis 102 facilitates faster procedure times, thus minimizingthe period of time during which blood flow is occluded.

More particularly, FIG. 1 is a perspective view of a delivery system 100for deploying a prosthesis 102 in one embodiment according to thepresent invention. For example, prosthesis 102 is a radially expandabletubular prosthesis such as a stent or stent-graft and is used to treatone of several vascular conditions: abdominal aortic aneurysms, thoracicaortic aneurysm, or thoracic aortic dissections.

Delivery system 100 includes a pushrod 104 and a sheath 106, sometimescalled a catheter sheath. Pushrod 104 includes a distal end 108 and aproximal end 110. Prosthesis 102 is placed over a portion of the distalend 108 of pushrod 104. In one embodiment, distal end 108 furtherincludes radiopaque markers that allow the location of distal end 108and proximal end of the prosthesis 102 (the proximal end of the deliverysystem is referenced with respect to the operator's handle while theproximal end of the prosthesis is referenced with respect to the endclosest to the heart (via the length of blood traveled from the heart)to be precisely tracked. Proximal end 110 of pushrod 104 terminateswithin and is mounted to a handle 112 or extends through handle 112 andout a port 114 of handle 112.

In this embodiment, pushrod 104 is a hollow tube whose interior acts asa guide wire lumen. A guide wire 116 extends through pushrod 104 andextends out distal end 108. Guide wire 116 further extends throughhandle 112 and out port 114.

Sheath 106 includes a distal end 120 and a proximal end 122. Prior todeployment, prosthesis 102 is radially compressed and restrained withindistal end 120 of sheath 106. Proximal end 122 of sheath 106 extendsinto handle 112. As discussed further below, proximal end 122 of sheath106 is slidably and threadedly coupled to handle 112. Sheath 106 is ahollow tube which acts as a pushrod lumen. Pushrod 104 extends throughsheath 106.

During use, prosthesis 102 is placed over a portion of the distal end108 of pushrod 104 and is radially compressed and restrained withindistal end 120 of sheath 106. Prosthesis 102 is introducedintra-vascularly and guided to the treatment site, e.g., an aneurysm.Once prosthesis 102 is properly positioned, sheath 106 is retracted bymanipulating handle 112 thus deploying prosthesis 102.

In one embodiment, prosthesis 102 is self-expandable. In accordance withthis embodiment, as sheath 106 is retracted, the released portion of theprosthesis 102 self-expands and is permanently deployed, e.g., anchoredwithin a lumen of a patient.

The guiding of prosthesis and deployment of a self-expanding prosthesisare well known to those of skill in the art.

FIG. 2 is a close up partial cutaway view of handle 112 of FIG. 1 beforeretraction of sheath 106. Referring now to FIGS. 1 and 2 together,handle 112 includes a slide ring 124. Rotation of slide ring 124 withrespect to longitudinal axis L of handle 112 (axial rotation) asindicated by arrow 126 is converted into axial translation, i.e.,retraction, of sheath 106 (as relative rotation of the threadedengagement between pieces causes a linear retraction of the sheath 106).This provides a mechanical advantage between handle 112 and sheath 106,helping the physician to overcome the large static frictional forcesbetween prosthesis 102 and sheath 106. This mechanical advantage alsohelps overcome any invagination of prosthesis 102 into sheath 106.

FIG. 3 is a close up partial cutaway view of handle 112 of FIG. 2 duringretraction of sheath 106. Referring now to FIGS. 2 and 3 together, slidering 124 includes a distal end 202 and a proximal end 204. Locatedwithin and coupled to slide ring 124 is a slide 206. In one embodiment,slide 206 includes a threaded outer surface 208 threadedly attached to athreaded inner surface 210 of slide ring 124.

Initially, slide 206 is located adjacent distal end 202 of slide ring124 as illustrated in FIG. 2. Axial rotation of slide ring 124 in adirection as indicated by arrow 126 causes axial translation of slide206 in a proximal direction as indicated by arrow 212 away from distalend 202 and towards proximal end 204 of slide ring 124.

Handle 112 includes a longitudinal axis L. As used herein, axialrotation is rotation around and in a plane perpendicular to longitudinalaxis L. Further, axial translation is motion along longitudinal axis L.Axial position is a particular position along longitudinal axis L.Angular position is a particular rotational position around and in aplane perpendicular to longitudinal axis L.

For example, slide 206 is illustrated as being in a first axial position220 adjacent distal end 202 of slide ring 124 in FIG. 2. Axial rotationof slide ring 124 in a direction as indicated by arrow 126 causes slide206 to move to a second axial position 222 adjacent proximal end 204 ofslide ring 124 as illustrated in FIG. 3.

Sheath 106 is coupled to slide 206 as discussed further below.Accordingly, axial translation of slide 206 is converted into axialtranslation, i.e., retraction, of sheath 106.

As a result, referring again to FIG. 1, a proximal end 128 of prosthesis102, which is deployed first, is very gradually released. In thismanner, the physician is allowed to verify the accuracy of thedeployment position as prosthesis 102 initially engages the surroundingbody lumen.

However, since the coefficient of dynamic friction is typically lowerthan the coefficient of static friction, the frictional resistance forcebetween prosthesis 102 and sheath 106 decreases once sheath 106 beginsto move. Additionally, as sheath 106 moves, more and more of prosthesis102 is exposed by sheath 106, i.e., the area of contact betweenprosthesis 102 and sheath 106 decreases. For this additional reason, theamount of frictional resistance to movement between prosthesis 102 andsheath 106 decreases once sheath 106 begins to move. Further, onceproximal end 128 of prosthesis 102 has firmly engaged the surroundingbody lumen, the relationship between prosthesis 102 and the surroundingbody lumen is largely set, so that deployment can proceed safely and ata more rapid rate.

Thus, after retraction of sheath 106 is initiated by axial rotation ofslide ring 124, retraction of sheath 106 is completed by axially pullingon slide ring 124 to slide ring 124. More particularly, after proximalend 128 of prosthesis 102 is deployed by retracting sheath 106 byrotating slide ring 124, slide ring 124 is easily and quickly slid alonglongitudinal axis L of handle 112 without further axial rotation ofslide ring 124. By sliding slide ring 124, sheath 106 is easily andquickly retracted thus rapidly completing deployment of prosthesis 102.Rapid deployment of prosthesis 102 facilitates faster procedure times,thus minimizing the period of time during which blood flow is occluded.

Sheath 106 is described above as being retracted by the combination ofaxial rotation of slide ring 124 followed by axial translation, i.e.,sliding, of slide ring 124 along longitudinal axis L of handle 112.However, in an alternative embodiment, sheath 106 can be retractedentirely by axial rotation of slide ring 124 (such a mode of retractionis not shown). Further, in yet another alternative embodiment, sheath106 can be retracted entirely by sliding of slide ring 124 alonglongitudinal axis L of handle 112 (for example without initiatingrotation of the handle in the above described embodiment).

FIG. 4 is a close up partial cutaway view of handle 112 of FIG. 3 duringretraction of sheath 106 in accordance with one embodiment of thepresent invention. Referring now to FIGS. 3 and 4 together, handle 112includes a slide shaft 402 having a distal end 404 and a proximal end406. Slide shaft 402 extends between a distal housing 410 and a proximalhousing 412 of handle 112. Slide 206 and slide ring 124 are slidablymounted on slide shaft 402.

A diameter D1 of slide shaft 402 is less than a proximal end diameter D2of distal housing 410 and is less than a diameter D3 of proximal housing412. Accordingly, slide ring 124 is capable of axial translation alongslide shaft 402 between distal housing 410 and proximal housing 412.Stated another way, distal housing 410 forms a forward stop for slidering 124 and proximal housing 412 forms a rear stop for slide ring 124.

Slide ring 124 is easily and quickly slid along slide shaft 402 ofhandle 112 from distal housing 410 to proximal housing 412. Since slide206 is threadedly engaged with (sometimes called threadedly attached) toslide ring 124, axial translation of slide ring 124 produces an axialtranslation of slide 206. Since slide 206 is coupled to sheath 106,axial translation of slide 206 produces an axial translation of sheath106. Overall, by sliding slide ring 124, sheath 106 is easily andquickly retracted thus rapidly completing deployment of prosthesis 102.

For example, slide ring 124 is illustrated as being adjacent distalhousing 410 of handle 112 in FIG. 3. Axial translation of slide ring 124as indicated by arrow 320 causes slide ring 124 and slide 206 to move toa third axial position 224 adjacent proximal housing 412 of handle 112as illustrated in FIG. 4. Sheath 106 is coupled to slide 206.Accordingly, axial translation of slide ring 124 also axiallytranslates, i.e., retracts, sheath 106.

FIG. 5 is a partial cross-sectional view of handle 112 taken at V-V ofFIG. 2. FIG. 6 is a cross-sectional view of handle 112 taken at VI-VI ofFIG. 5.

In one embodiment, slide ring 124 includes at least two sections joinedtogether. However, in an alternative embodiment, slide ring 124 isintegral, i.e., is a single piece not a plurality of pieces connectedtogether.

Referring now to FIGS. 5 and 6 together, slide ring 124 is cylindricaland includes threaded inner surface 210. In one embodiment, threadedinner surface 210 is a cylindrical surface formed with a continuousthread (sometimes called a series of threads), e.g., internal threads.

Slide 206 includes an outer body 502, an inner body 504, and couplers602, which couple outer body 502 to inner body 504 as discussed furtherbelow. In one embodiment, outer body 502 is cylindrical and is outsideand encloses slide shaft 402, which is also cylindrical.

Outer body 502 includes threaded outer surface 208. In one embodiment,threaded outer surface 208 is a cylindrical surface formed with acontinuous thread (sometimes called a series of threads), e.g., externaland helical threads. More particularly, threaded outer surface 208 is acylindrical surface formed with a continuous series of high points whichtogether form a helical thread pattern.

Threaded outer surface 208 of outer body 502 is threaded with threadedinner surface 210 of slide ring 124. More particularly, the externalthreads of threaded outer surface 208 are engaged with the internalthreads of threaded inner surface 210 of slide ring 124. However, inalternative embodiments, threaded outer surface 208 can be formed withpins, tabs or other protrusions which mate (or engage) with the threadsof threaded inner surface 210 of slide ring 124.

Rotation of slide ring 124 with respect to the slide causes slide 206 tomove linearly while its threads track along a helical path of the seriesof threads of threaded inner surface 210 of slide ring 124. Moreparticularly, rotation of slide ring 124 causes threaded outer surface208 of slide 206 to track the helical path of the series of threads ofthreaded inner surface 210 of slide ring 124. As threaded outer surface208 of slide 206 track the helical path of the series of threads ofthreaded inner surface 210, slide 206 translates in direction 320 (FIG.4) along longitudinal axis L.

Inner body 504 is inside and located within slide shaft 402. Inner body504 has a central aperture 506 through which pushrod 104 extends.Pushrod 104 has a guide wire lumen 505 through which a guide wire 116extends. Proximal end 122 of sheath 106 is attached to inner body 504,for example, using adhesive or screws.

Slide shaft 402 includes opposing slots 604. Couplers 602 extend throughslots 604 and couple outer body 502 to inner body 504. By extendingthrough slots 604, couplers 602 prevent rotation of slide 206 and thusof sheath 106 with respect to slide shaft 402.

In one embodiment, slide 206 is integral, i.e., outer body 502, innerbody 504, and couplers 602 are parts of a single piece and are not aplurality of separate pieces connected together. However, in analternative embodiment, outer body 502, inner body 504, and/or couplers602 are separate pieces connected together. For example, couplers 602can be set screws, tabs protruding radially inward or outward from outerbody 502 and/or inner body 504, respectively.

FIG. 7 is a close up partial cutaway view of handle 112 of FIG. 1 beforeretraction of sheath 106 in another embodiment according to the presentinvention. Referring now to FIGS. 1 and 7 together, handle 112 includesa hub assembly 702. Axial rotation of hub assembly 702 in a direction asindicated by arrow 126 is converted into axial translation, i.e.,retraction, of sheath 106. This provides a mechanical advantage betweenhandle 112 and sheath 106, helping the physician to overcome therelatively larger static frictional resistance between prosthesis 102and sheath 106. This mechanical advantage also helps overcome anyinvagination of prosthesis 102 into sheath 106.

FIG. 8 is a close up partial cutaway view of handle 112 of FIG. 7 duringretraction of sheath 106. Referring now to FIGS. 7 and 8 together, hubassembly 702 includes a slide ring 124A and a hub 704. Slide ring 124A,sometimes called a cam-lock ring, is mounted on hub 704. For example,slide ring 124A and hub 704 are molded parts fixedly mounted together.

Hub 704 includes a selectively engaging member 706. By rotating slidering 124A, selectively engaging member 706 and thus hub assembly 702 isselectively engaged (FIG. 7) and disengaged (FIG. 8) from a pushrod104A. To illustrate, in one embodiment, selectively engaging member 706includes an inside threaded surface 708 and pushrod 104A includes athreaded outer surface 710, sometimes called an external threadedsurface 710. In one embodiment, inside threaded surface 708 and externalthreaded surface 710 each include a continuous series of threads, e.g.,helical threads. Stated another way, inside threaded surface 708 andexternal threaded surface 710 each are a continuous thread.

By rotating slide ring 124A in a first direction, e.g.,counterclockwise, threaded surface 708 of selectively engaging member706 is pressed into threaded engagement (attachment) with threaded outersurface 710 of pushrod 104A as illustrated in FIG. 7. Thus, rotation ofslide ring 124A in the first direction engages selectively engagingmember 706 with pushrod 104A. More generally, rotation of slide ring124A in the first direction engages and threadably attaches (mounts) hubassembly 702 with pushrod 104A.

Initially, selectively engaging member 706 is engaged with pushrod 104Aas illustrated in FIG. 7. Axial rotation of hub assembly 702 in adirection of rotation as indicated by arrow 126 causes axial translationof hub assembly 702 in an axial direction as indicated by arrow 712 awayfrom distal housing 410 and towards proximal housing 412 of handle 112.More particularly, axial rotation of hub assembly 702 causes hubassembly 702 to move along a helical path of the thread of threadedouter surface 710 of pushrod 104A.

For example, hub assembly 702 is illustrated as being in a first axialposition 730 adjacent distal housing 410 of handle 112 in FIG. 7. Axialrotation of hub assembly 702 in a direction as indicated by arrow 126causes hub assembly 702 to move to a second axial position 732 betweendistal housing 410 and proximal housing 412 of handle 112 as illustratedin FIG. 8. Stated another way, axial rotation of hub assembly 702 causesaxial translation of hub assembly 702.

Sheath 106 is coupled to hub assembly 702 as discussed further below.Accordingly, axial translation of hub assembly 702 causes axialtranslation, i.e., retraction, of sheath 106.

As a result, referring again to FIG. 1, a proximal end 128 of prosthesis102, which is deployed first, is very gradually released. In thismanner, the physician is allowed to verify the accuracy of thedeployment position as prosthesis 102 initially engages the surroundingbody lumen.

Further, after proximal end 128 of prosthesis 102 is deployed byretracting sheath 106 by rotating hub assembly 702 as discussed above,selectively engaging member 706 is selectively disengaged from pushrod104A as illustrated in FIG. 8.

In accordance with one embodiment, by rotating slide ring 124A in asecond direction opposite the first direction, e.g., clockwise, threadedsurface 708 of selectively engaging member 706 is released (retracted)from threaded attachment with threaded outer surface 710 of pushrod104A. Thus, rotation of slide ring 124A in the second directiondisengages selectively engaging member 706, and thus hub assembly 702,from pushrod 104A.

Once disengaged, hub assembly 702 is slidably mounted on pushrod 104A.More particularly, hub assembly 702 is supported around pushrod 104A bysheath 106. Thus, hub assembly 702 is easily and quickly slid alongpushrod 104A and longitudinal axis L of handle 112 without furtherrotation of hub assembly 702. By sliding hub assembly 702, sheath 106 iseasily and quickly retracted thus rapidly completing deployment ofprosthesis 102. Rapid deployment of prosthesis 102 facilitates fasterprocedure times, thus minimizing the period of time during which bloodflow is occluded.

Sheath 106 is described above as being retracted by the combination ofaxial rotation of hub assembly 702 followed by sliding, i.e., axialtranslation, of hub assembly 702 along longitudinal axis L of handle112. However, in an alternative embodiment, sheath 106 is retractedentirely by axial rotation of hub assembly 702. Further, in yet anotherembodiment, sheath 106 is retracted entirely by sliding of hub assembly702 along longitudinal axis L of handle 112.

In yet another embodiment, hub assembly 702 is initially engaged withpushrod 104A. Sheath 106 is initially retracted by axial rotation of hubassembly 702. Hub assembly 702 is then disengaged from pushrod 104A.Sheath 106 is further retracted by sliding of hub assembly 702 alonglongitudinal axis L of handle 112. Hub assembly 702 is again engagedwith pushrod 104A. For example, if the deployment force, e.g., friction,increases and the physician desires more mechanical advantage forfurther deployment of sheath 106. Sheath 106 is then further retractedby axial rotation of hub assembly 702. In the above manner, sheath 106is retracted rapidly by sliding of hub assembly 702. However, at anytime during retraction, hub assembly 702 can be engaged with pushrod104A for more mechanical advantage and control of sheath 106.

As shown in FIG. 8, pushrod 104A extends between distal housing 410 andproximal housing 412 of handle 112. In one embodiment, distal housing410 and proximal housing 412 are connected to and supported by a supportmember (not shown).

When disengaged, hub assembly 702 is easily and quickly slid alongpushrod 104A of handle 112 from distal housing 410 to proximal housing412. Since hub assembly 702 is coupled to sheath 106, axial translationof hub assembly 702 produces an axial translation of sheath 106.Overall, by sliding hub assembly 702, sheath 106 is easily and quicklyretracted thus rapidly completing deployment of prosthesis 102.

For example, hub assembly 702 is illustrated as being at second axialposition 732 between distal housing 410 and proximal housing 412 ofhandle 112 in FIG. 8. Axial translation of hub assembly 702 in adirection as indicated by arrow 720 causes hub assembly 702 to move to athird axial position 734 adjacent proximal housing 412 of handle 112 asindicated by the dashed lines in FIG. 8. Sheath 106 is coupled to hubassembly 702. Accordingly, axial translation of hub assembly 702 causesaxial translation, i.e., retraction, of sheath 106.

FIG. 9 is a cross-sectional view of handle 112 taken at IX-IX of FIG. 7.FIG. 10 is a cross-sectional view of handle 112 taken at X-X of FIG. 9.

Referring now to FIGS. 9 and 10 together, hub assembly 702 includes hub704. Hub 704 includes a cylindrical body 950 and selectively engagingmember 706. In accordance with this embodiment, selectively engagingmember 706 includes a first spring arm 902A and a second spring arm902B, collectively spring arms 902. Spring arms 902 terminate atthreaded surface 708.

In accordance with this embodiment, spring arms 902A, 902B include upperarms 952A, 952B and lower arms 954A, 954B connected together at elbows956A, 956B. Upper arms 952A, 952B, lower arms 954A, 954B and elbows956A, 956B are collectively referred to as upper arms 952, lower arms954 and elbows 956, respectively.

First ends 958 of upper arms 952 are connected to cylindrical body 950.Second ends 960 of upper arms 952 are connected to first ends 962 oflower arms 954.

Second ends 964 of lower arms 954A, 954B include threaded surfaces 708A,708B, respectively. Threaded surfaces 708A, 708B are collectivelyreferred to as threaded surface 708.

Sheath 106 is rotationally mounted to hub 704 by a bearing 906. Bearing906 allows hub assembly 702 including hub 704 to be rotating withoutimparting any rotation to sheath 106.

Slide ring 124A is rotationally mounted on hub 704. Illustratively, hub704 includes flanges 908, 910, which fit into tracks 912, 914 of slidering 124A. Thus, slide ring 124 is mounted on hub 704, yet, is capableof angular rotation relative to hub 704.

Referring now to FIG. 10, slide ring 124A is cylindrical and includes aninner surface 916. Tracks 912, 914 of slide ring 124A are formed ininner surface 916. Slide ring 124A further includes tabs 918A, 918B,collectively tabs 918, protruding inwards from inner surface 916.

Slide ring 124A is in a lock position 1002 in FIG. 10, i.e., is at aparticular angular position relative to hub 704. When in lock position1002, tabs 918 are engaged with and press inwards on spring arms 902.More particularly, elbows 956 of spring arms 902 are seated withinnotches 926A, 926B, collectively notches 926, of tabs 918A, 918B,respectively, when slide ring 124A is in lock position 1002.

This forces threaded surface 708 of spring arms 902 to engage threadedouter surface 710 of pushrod 104A. In this manner, hub assembly 702 isengaged with pushrod 104A.

To move hub assembly 702 relative to pushrod 104A, hub assembly 702 isrotated. The engagement of threaded surface 708 of selectively engagingmember 706 to threaded outer surface 710 of pushrod 104A translates thisaxial rotation into axial translation of hub assembly 702.

In one embodiment, the direction in which slide ring 124A is rotated toengage hub assembly 702 with pushrod 104A, i.e., the first direction, isthe same direction in which hub assembly 702 is rotated to retractsheath 106. In accordance with this embodiment, axial rotation of slidering 124A in the first direction serves at least two purposes.

First, axial rotation of slide ring 124A seats spring arms 902 withinnotches 926 to engage threaded surface 708 of selectively engagingmember 706 with threaded outer surface 710 of pushrod 104A. Second, oncespring arms 902 are seated within notches 926, further axial rotation ofslide ring 124A causes rotation of hub 704 and axial translation of hubassembly 702.

FIG. 11 is a cross-sectional view of handle 112 taken at XI-XI of FIG.8. FIG. 12 is a cross-sectional view of handle 112 taken at XII-XII ofFIG. 11.

Referring now to FIGS. 11 and 12 together, slide ring 124A is in anunlock position 1202 in FIG. 12, i.e., is at a second particular angularposition relative to hub 704. For example, unlock position 1202 is 90degrees from lock position 1002. In one embodiment, hub 704 is formedwith stops 940A, 940B, collectively stops 940, which protrude outwardsfrom hub 704 and engage tabs 918 to prevent slide ring 124A from beingrotated past unlock position 1202.

When in unlock position 1202, tabs 918 are away from and are not engagedwith spring arms 902. Spring arms 902 and, more particularly, upper arms952, are resilient members. In one embodiment, when relaxed, spring arms902 are positioned away from pushrod 104A. Stated another way, slidering 124A places spring arms 902 under tension to engage spring arms 902with pushrod 104A as illustrated in FIG. 10. However, when slide ring124A is moved to unlock position 1202 as shown in FIG. 12, spring arms902 return to their relaxed position adjacent inner surface 916 of slidering 124A.

Thus, when slide ring 124A is in unlock position 1202 as shown in FIG.12, threaded surface 708 of selectively engaging member 706 isdisengaged from threaded outer surface 710 of pushrod 104A. This allowshub assembly 702 to be readily and easily slid along pushrod 104A asdiscussed above.

FIG. 13 is an enlarged cross-sectional view of the region XIII ofpushrod 104A of FIG. 11 in accordance with one embodiment of the presentinvention. In accordance with this embodiment, threads 1302 of threadedouter surface 710 of pushrod 104A are buttress threads. Threads 1302include angled surfaces 1304 in one direction and flat surfaces 1306 inthe other.

Angled surfaces 1304 are at an angle to a plane perpendicular tolongitudinal axis L. Stated another way, angled surfaces 1304 are angledrelative to the direction normal to longitudinal axis L.

In contrast, flat surfaces 1306 are parallel to a plane perpendicular tolongitudinal axis L. Stated another way, flat surfaces 1306 are in thedirection normal to longitudinal axis L.

During rotation of hub assembly 702 as discussed above, referring now toFIGS. 9 and 13 together, threaded surface 708 of selectively engagingmember 706 is forced against flat surfaces 1306 of pushrod 104A. In thismanner, force is applied to selectively engaging member 706 in adirection parallel to longitudinal axis L thus causing axial translationof hub assembly 702. However, there is essentially no force applied toselectively engaging member 706 in the direction normal to longitudinalaxis L. This essentially eliminates the possibility of spring arms 902being forced apart and the associated slipping of hub assembly 702 onpushrod 104A.

However, in an alternative embodiment, threads 1302 are formed, forexample, in a conventional profile, to impart force to selectivelyengaging member 706 in the direction normal to longitudinal axis L. Forexample, when a high load is imparted to hub assembly 702, e.g., whensheath 106 is stuck, spring arms 902 are forced apart and hub assembly702 slips on pushrod 104A. This prevents damage to sheath 106 andcomplications in the deployment of prosthesis 112 (FIG. 1).

As discussed above, selectively engaging member 706 includes two springarms 902, i.e., spring arms 902A, 902B, as shown in FIGS. 9 and 10.Spring arms 902 extend around and contact approximately two-thirds ofthe circumference of pushrod 104A. However, in one embodiment,selectively engaging member 706 includes only spring arm 902A or springarm 902B, and not both. In yet another embodiment, selectively engagingmember 706 includes three or more spring arms 902.

In yet other alternative embodiments, selectively engaging member 706 isa spring-loaded mechanism. This spring-loaded mechanism is biased suchthat it is engaged or disengaged with pushrod 104A when thespring-loaded mechanism is in its relaxed state. For example, thespring-loaded mechanism includes a screw that is engaged with pushrod104A when the spring-loaded mechanism is in its relaxed position. Thespring-loaded mechanism further includes a button, which is pressed todisengaged the screw. This button is integrated into hub assembly 702,or is mounted as a separate button or a trigger-type mechanism. However,other spring-loaded mechanisms are used in other embodiments.

Further, in one embodiment, a ratchet or pawl is used to preventunintentional or undesirable axial rotation or axial translation. Forexample, a ratchet or pawl is used to prevent slide rings 124, 124A(FIGS. 2, 7) from axial rotation in the direction opposite arrow 126. Asa further example, a ratchet or pawl is used to prevent slide ring 124,hub assembly 702 (FIGS. 4, 8) from moving backwards toward distalhousing 410.

FIGS. 14 and 15 are perspective and side views of another embodiment ofdelivery system 100B according to the present invention. FIG. 16 is aside view, partially in cross-section, of delivery system 100B of FIGS.14 and 15 after retraction of a sheath 106B.

Referring now to FIGS. 14, 15 and 16 together, delivery system 100Bincludes a handle 112B. Handle 112B includes a distal housing 1402,sometimes called a front grip, a hub assembly 1404, sometimes called anexternal slider, and a proximal housing 1406, sometimes called a reargrip. Handle 112B further includes a slide shaft 1408, sometimes calleda screw gear, extending between distal housing 1402 and proximal housing1406.

Slide shaft 1408 is a hollow tubular member and includes opposing slots1410 (FIG. 14). Slide shaft 1408 includes a threaded outer surface 1412,e.g., a buttress thread.

Hub assembly 1404 is selectively engaged and disengaged with threadedouter surface 1412 of slide shaft 1408 by motion of a thumb slider 1414,sometimes called an actuation button.

When engaged, i.e., threadedly attached, with threaded outer surface1412 of slide shaft 1408, axial rotation of hub assembly 1404 asindicated by arrow 126 (FIG. 14) is converted into axial translation,i.e., retraction, of sheath 106B of delivery system 100B. Sheath 106B iscoupled to hub assembly 1404.

As a result, a proximal end 128B (FIG. 16) of a prosthesis 102B, whichis deployed first, is very gradually released through axial rotation ofhub assembly 1404. In this manner, the physician is allowed to verifythe accuracy of the deployment position as prosthesis 102B initiallyengages the surrounding body lumen.

Further, when disengaged from threaded outer surface 1412 of slide shaft1408, hub assembly 1404 is slidably mounted on slide shaft 1408. Whenhub assembly 1404 is slidably mounted on slide shaft 1408, hub assembly1404 is easily and quickly slid along slide shaft 1408. By sliding hubassembly 1404, sheath 106B is easily and quickly retracted thus rapidlycompleting deployment of prosthesis 102B. Rapid deployment of prosthesis102B facilitates faster procedure times, thus minimizing the period oftime during which blood flow is occluded.

Sheath 106B is described above as being retracted by the combination ofaxial rotation of hub assembly 1404 followed by sliding, i.e., axialtranslation, of hub assembly 1404 along a longitudinal axis L of handle112B. However, in an alternative embodiment, sheath 106B is retractedentirely by axial rotation of hub assembly 1404. Further, in yet anotherembodiment, sheath 106B is retracted entirely by sliding of hub assembly1404 along longitudinal axis L of handle 112B.

In yet another embodiment, hub assembly 1404 is initially engaged withthreaded outer surface 1412 of slide shaft 1408. Sheath 106B isinitially retracted by axial rotation of hub assembly 1404.

Hub assembly 1404 is then disengaged from threaded outer surface 1412 ofslide shaft 1408. Sheath 106B is further retracted by sliding of hubassembly 1404 along longitudinal axis L of handle 112B.

Hub assembly 1404 is again engaged with threaded outer surface 1412 ofslide shaft 1408, for example, if the deployment force, e.g., friction,increases and the physician desires more mechanical advantage forfurther deployment of sheath 106B. Sheath 106B is then further retractedby axial rotation of hub assembly 1404. In the above manner, sheath 106Bis retracted rapidly by sliding of hub assembly 1404. However, at anytime during retraction, hub assembly 1404 can be engaged with threadedouter surface 1412 of slide shaft 1408 for more mechanical advantage andcontrol of sheath 106B.

FIG. 17 is an enlarged side view, partially in cross-section, of theregion XVII of handle 112B of FIG. 16. Referring now to FIG. 17, sheath106B extends through a strain relief 1702 at a distal end 1704 of distalhousing 1402. Strain relief 1702 distributes stress from distal housing1402 onto sheath 106B thus preventing kinking or other damage to sheath106B at the location where the sheath tube exits the front grip. Sheath106B is coupled to a slide 1706 of hub assembly 1404.

Slide (T-tube assembly) 1706 is in the shape of a T and includes anouter body (two oppositely positioned members) 1708, an inner body(tube) 1710, and couplers (two oppositely extending members(fins)) 1712,which couple outer body 1708 to inner body 1710 as discussed furtherbelow. In one embodiment, outer body 1708 is outside of a cylindricalslide shaft 1408.

Outer body 1708 is slidably mounted within a circumferential channel1714 of an external housing 1716 of hub assembly 1404. Moreparticularly, circumferential channel 1714 is defined by a distalannular stop 1718, a proximal annular stop 1720, and a taperingcylindrical portion 1722 of external housing 1716.

Distal and proximal annular stops 1718 and 1720 prevent longitudinalmotion of outer body 1708 and thus slide 1706 relative to externalhousing 1716. However, external housing 1716 is rotatable relative toouter body 1708 and thus slide 1706. More particularly, as externalhousing 1716 is rotated, outer body 1708 though rotationally stationaryslides within rotating circumferential channel 1714.

Inner body (tube) 1710 is inside and located within slide shaft 1408.Inner body 1710 includes central aperture 1724 through which a pushrod104B extends. The proximal end of sheath 106B is attached to inner body(tube) 1710, for example, using adhesive or screws. The distal end ofthe inner body include one or more support rings; e.g., 1710A, 1710B;which prevent the collapse or deflection of the side walls of theslotted portion of the slide shaft 1408 when engaged by the hubassembly.

As set forth above, slide shaft 1408 includes opposing slots 1410.Couplers 1712 extend through slots 1410 and couple outer body 1708 toinner body 1710. By extending through slots 1410, couplers 1712 preventrotation of slide 1706 and thus of sheath 106B with respect to slideshaft 1408.

In one embodiment, slide 1706 is integral, i.e., outer body 1708, innerbody 1710, and couplers 1712 are parts of a single piece and are not aplurality of separate pieces connected together. However, in analternative embodiment, outer body 1708, inner body 1710, and/orcouplers 1712 are separate pieces connected together.

Hub assembly 1404 further includes an internal slider subassembly 1730,sometimes called a selectively engaging member. With the exception ofthumb slider 1414, the internal slider subassembly 1730 is locatedwithin external housing 1716. Thumb slider 1414 is part of a sleeve 1732of internal slider subassembly 1730 and extends through a thumb sliderslot 1734 of external housing 1716. Thumb slider 1414, and thus sleeve1732 of internal slider subassembly 1730 are moved, e.g., by thephysician, relative to external housing 1716 to selectively engage anddisengage hub assembly 1404 from threaded outer surface 1412 of slideshaft 1408.

FIGS. 18, 19 and 20 are side, top and exploded views of internal slidersubassembly 1730. Referring now to FIGS. 18, 19 and 20, internal slidersubassembly 1730 includes an inner slider 1802, a pair of opposingthread teeth 1804A, 1804B, a spring 1806, and a spring retainer 1808.Although two thread teeth 1804A, 1804B are illustrated and discussedbelow, other numbers of thread teeth 1804 and corresponding structureare used in other embodiments, e.g., one, three, four, five or more.

Referring now to FIG. 20, inner slider 1802 includes a generallycylindrical body 1810, a distal stop 1812, and a proximal springretainer mounting section 1814.

Body 1810 includes a pair of opposing distal thread teeth pivotapertures 1816A, 1816B, a pair of opposing proximal thread teeth pivotapertures 1818A, 1818B, and a pair of opposing thread teeth flat (notarc shaped) pivot supports 1820A, 1820B (proximal thread tooth pivotaperture 1818B and thread tooth pivot support 1820B are not illustratedin the view of FIG. 20, see FIGS. 21 and 22). Collectively, distalthread teeth pivot apertures 1816A, 1816B, proximal thread teeth pivotapertures 1818A, 1818B, and thread teeth pivot supports 1820A, 1820B aresometimes referred to as distal or first thread teeth pivot apertures1816, proximal or second thread teeth pivot apertures 1818, and threadteeth pivot supports 1820, respectively.

Thread tooth pivot support 1820A approximates a circumferential member,i.e., has a length along the circumference of body 1810, but actually isa flat element (like the chord of a circle to the linear pivot axis).However, in another embodiment, tooth pivot support 1820A is a curvedcircumferential member, e.g., a segment of a circle. Thread tooth pivotsupport 1820A is between and separates distal thread tooth pivotaperture 1816A and proximal thread tooth pivot aperture 1818A.

Thread tooth pivot support 1820A includes a protruding pivot pin 1822A,which seats in a pivot pin aperture 1824A of thread tooth 1804A althoughin one embodiment, pivot pin 1822A and pivot pin aperture 1824A are notused. Accordingly, thread tooth 1804A is pivotally mounted to threadtooth pivot support 1820A and thus inner slider 1802.

As discussed further below, thread tooth 1804A pivots back and forth(proximally and distally) on thread tooth pivot support 1820A into andout of proximal thread tooth pivot aperture 1818A and distal threadtooth pivot aperture 1816A.

Thread tooth pivot support 1820B (see FIG. 21) is similar to threadtooth pivot support 1820A. Thread tooth pivot support 1820B is betweenand separates distal thread tooth pivot aperture 1816B and proximalthread tooth pivot aperture 1818B.

Thread tooth pivot support 1820B includes a protruding pivot pin 1822B(see FIG. 21), which seats in a pivot pin aperture 1824B of thread tooth1804B although in one embodiment, pivot pin 1822B and pivot pin aperture1824B are not used. Accordingly, thread tooth 1804B is pivotally mountedto thread tooth pivot support 1820B and thus inner slider 1802.

As discussed further below, thread tooth 1804B pivots back and forth(proximally and distally) on thread tooth pivot support 1820B into andout of proximal thread tooth pivot aperture 1818B and distal threadtooth pivot aperture 1816B.

Sleeve 1732 includes a pair of opposing proximal thread teeth pivotapertures 1830A, 1830B, a pair of opposing distal thread teeth pivotcutouts 1832A, 1832B, and a pair of opposing thread teeth press members1834A, 1834B. Collectively, proximal thread teeth pivot apertures 1830A,1830B, distal thread teeth pivot cutouts 1832A, 1832B, and thread teethpress members 1834A, 1834B are sometimes referred to as proximal threadteeth pivot apertures 1830, distal thread teeth pivot cutouts 1832, andthread teeth press members 1834, respectively.

Sleeve 1732 is generally cylindrical and has an inner diameter slightlygreater than an outer diameter of body 1810 of inner slider 1802. Thisallows sleeve 1732 to be slipped over and located around body 1810 ofinner slider 1802.

One or more longitudinal lips 1836 protrude inwards from an innersurface 1838 of sleeve 1732. Lips 1836 mate with longitudinal slots 1840in an outer surface 1842 of body 1810 of inner slider 1802. Slots 1840have a greater length than lips 1836 allowing lips 1836 to be slidlongitudinally back and forth within slots 1840. In this manner,longitudinal motion of sleeve 1732 relative to inner slider 1802 ispermitted while rotation of sleeve 1732 relative to inner slider 1802 isprevented.

Thread tooth press member 1834A is a circumferential member, i.e., has alength along the circumference of sleeve 1732. Thread tooth press member1834A is between and separates distal thread tooth pivot cutout 1832Aand proximal thread tooth pivot aperture 1830A.

As discussed further below, thread tooth press member 1834A presses onand pivots thread tooth 1804A back and forth as sleeve 1732 is movedlongitudinally relative to inner slider 1802.

Similarly, thread tooth press member 1834B is a circumferential member,i.e., has a length along the circumference of sleeve 1732. Thread toothpress member 1834B is between and separates distal thread tooth pivotcutout 1832B and proximal thread tooth pivot aperture 1830B.

As discussed further below, thread tooth press member 1834B presses onand pivots thread tooth 1804B back and forth as sleeve 1732 is movedlongitudinally relative to inner slider 1802.

Spring retainer 1808 is mounted around spring retainer mounting section1814 of inner slider 1802. Spring 1806 is mounted around inner slider1802 and is located longitudinally between sleeve 1732 and a proximalspring stop 1844 of spring retainer 1808.

Spring 1806 is compressed between spring stop 1844 of spring retainer1808 and a proximal end 1846 of sleeve 1732. Due to this compression ofspring 1806, spring 1806 urges sleeve 1732 distally and against distalstop 1812 of inner slider 1802.

Distal stop 1812 of inner slider 1802 includes opposing cutouts 1848A,1848B, collectively cutouts 1848. Thread teeth 1804A, 1804B includeextending fingers 1850A, 1850B, collectively fingers 1850, which seat incutouts 1848A, 1848B, respectively as thread teeth 1804 are pivoted.Further, thread teeth 1804A, 1804B include inward protruding teeth1852A, 1852B, collectively protruding teeth 1852, respectively.

FIG. 21 is a cross-sectional and partially cutaway view of handle 112Balong the line XXI-XXI of FIG. 18 with hub assembly 1404 engaged withthreaded outer surface 1412 of slide shaft 1408. Referring now to FIG.21, thread teeth press members 1834 are pressing on thread teeth 1804opposite of protruding teeth 1852. More particularly, thread teeth pressmembers 1834 press protruding teeth 1852 into threaded engagement withthreaded outer surface 1412, e.g., a helical thread pattern, of slideshaft 1408. As shown in FIG. 21, thread teeth 1804 are pivoted distallyand into distal thread teeth pivot apertures 1816 of inner slider 1802.

In FIG. 21, the inner body (tube) 1710 with its supports 1710A, 1710Bare shown connected to the sheath 106B which is shown partially cutaway.Sheath 106B is a hollow tube and includes a pushrod lumen. Pushrod 104Bextends through sheath 106B. Pushrod 104B is also shown partiallycutaway. Pushrod 104B is a hollow tube and includes a lumen. A guidewirelumen 2102 extends through pushrod 104B. Guidewire lumen 2102 is ahollow tube and includes a lumen. Guidewire lumen 2102 is also shownpartially cutaway. A guidewire 2104 extends through guidewire lumen2102. In FIG. 22, pushrod 104B, guidewire lumen 2102 and guidewire 2104are not illustrated for clarity of presentation.

FIG. 22 is a cross-sectional view of handle 112B of FIG. 21 with hubassembly 1404 disengaged from threaded outer surface 1412 of slide shaft1408. Referring now to FIGS. 21 and 22 together, thread teeth 1804 arecurved members. Accordingly, when thread teeth 1804 are located indistal thread teeth pivot apertures 1816 (FIG. 21), thread teeth 1804pivot on thread teeth pivot supports 1820 and protrude above proximalthread teeth pivot apertures 1818 of inner slider 1802 and into proximalthread teeth pivot apertures 1830 of sleeve 1732. Conversely, whenthread teeth 1804 are located in proximal thread teeth pivot apertures1818 (FIG. 22), thread teeth 1804 pivot on thread teeth pivot supports1820 and protrude above distal thread teeth pivot apertures 1816 ofinner slider 1802 and into distal thread teeth cutouts 1832 of sleeve1732.

Thread teeth 1804 are pivoted on thread teeth pivot supports 1820 assleeve 1732 is slid longitudinally, e.g., by pulling or releasing thumbslider 1414 (see FIG. 17). Specifically, when sleeve 1732 is slidproximally by the physician pulling on thumb slider 1414, thread teethpress members 1834 slide proximally on thread teeth 1804. As threadteeth press members 1834 slide proximally on thread teeth 1804longitudinally past thread teeth pivot supports 1820, thread teeth pressmembers 1834 pivot thread teeth 1804 and move protruding teeth 1852 outof threaded engagement with threaded outer surface 1412 of slide shaft1408 such that protruding teeth 1852 are spaced apart from threadedouter surface 1412 as shown in FIG. 22.

Conversely, when sleeve 1732 is slid distally, e.g., by spring 1806 uponthe physician releasing thumb slider 1414, thread teeth press members1834 slide distally on thread teeth 1804. As thread teeth press members1834 slide distally on thread teeth 1804 longitudinally past threadteeth pivot supports 1820, thread teeth press members 1834 pivot threadteeth 1804 and move protruding teeth 1852 into threaded engagement withthreaded outer surface 1412 of slide shaft 1408 as shown in FIG. 21.

FIGS. 23 and 24 are exploded and side views, respectively, of a graftcover subassembly and RO radiopaque marker 2300 of delivery system 100B.Illustrative descriptions of the various elements shown in FIGS. 23 and24 are set forth below in table 1.

TABLE 1 ELEMENT DESCRIPTION 23-4  O-ring 23-6  Graft cover 23-7  T-tubesubassembly 23-8  Hub cap 23-11 RO marker

FIGS. 25 and 26 are exploded and side views, respectively, of a strainrelief subassembly 2500 of delivery system 100B. Strain reliefsubassembly 2500 protects Illustrative descriptions of the variouselements shown in FIGS. 25 and 26 are set forth below in table 2.

TABLE 2 ELEMENT DESCRIPTION 34-9  Strain relief tubing 34-10 Strainrelief

This disclosure provides exemplary embodiments of the present invention.The scope of the present invention is not limited by these exemplaryembodiments. Numerous variations, whether explicitly provided for by thespecification or implied by the specification or not, such as variationsin structure, dimension, type of material and manufacturing process maybe implemented by one of skill in the art in view of this disclosure.

1. A method comprising: engaging a hub assembly of a handle to athreaded outer surface of a slide shaft of said handle, wherein saidslide shaft extends between a distal housing of said handle and aproximal housing of said handle; rotating said hub assembly to causeaxial translation of said hub assembly and a sheath coupled to said hubassembly relative to a pushrod and prosthesis inside of said sheath,wherein said slide shaft comprises slots, said sheath being coupled to aslide of said hub assembly, said slide extending through said slots;disengaging said hub assembly from said threaded outer surface bypivoting a thread tooth of said hub assembly out of threaded engagementwith said threaded outer surface; and sliding said hub assembly on saidslide shaft to further retract said sheath.
 2. A method comprising:engaging a hub assembly of a handle to a threaded outer surface of aslide shaft of said handle; rotating said hub assembly to cause axialtranslation of said hub assembly and a sheath coupled to said hubassembly relative to a pushrod and prosthesis inside of said sheath;disengaging said hub assembly from said threaded outer surface bypivoting a thread tooth of said hub assembly out of threaded engagementwith said threaded outer surface, wherein said hub assembly furthercomprises a sleeve and an inner slider, said disengaging comprisingmoving said sleeve relative to said inner slider; and sliding said hubassembly on said slide shaft to further retract said sheath.
 3. Themethod of claim 2 wherein said disengaging comprises pulling a thumbslider of said hub assembly.
 4. The method of claim 3 wherein saidpulling comprises sliding a thread tooth press member across said threadtooth.
 5. The method of claim 4 wherein said thread tooth press memberpivots said thread tooth as said thread tooth press member is slid pasta thread tooth pivot support pivotally coupled to said thread tooth. 6.The method of claim 2 wherein said prosthesis is located over saidpushrod and restrained within said sheath.
 7. The method of claim 6wherein said rotating comprising retracting said sheath to initiatedeployment of said prosthesis.
 8. The method of claim 7 wherein saidsliding comprising completing said deployment of said prosthesis.
 9. Themethod of claim 2 wherein said pushrod comprises a guide wire lumen. 10.The method of claim 9 wherein a guidewire extends through said guidewire lumen.
 11. The method of claim 2 wherein said slide shaft extendsbetween a distal housing of said handle and a proximal housing of saidhandle.
 12. The method of claim 2 wherein said thread tooth is pivotallymounted to a thread tooth pivot support facilitating proximal and distalpivoting of said thread tooth.
 13. The method of claim 2 wherein saidsleeve comprises a thread tooth press member pressing on said threadtooth.
 14. The method of claim 13 wherein said thread tooth press memberpresses on said thread tooth opposite a protruding tooth of said threadtooth when said hub assembly is engaged to said threaded outer surface.15. The method of claim 13 wherein said thread tooth is pivoted distallyinto threaded engagement with said threaded outer surface by said threadtooth press member.
 16. The method of claim 13 wherein said disengagingcomprises sliding said thread tooth press member past a thread toothpivot support of said inner slider, said thread tooth being pivotallymounted to said thread tooth pivot support.
 17. The method of claim 16wherein said thread tooth press member proximally pivots said threadtooth as said thread tooth press member is slid past said thread toothpivot support.
 18. The method of claim 17 wherein said thread tooth isproximally pivoted out of threaded engagement with said threaded outersurface.
 19. The method of claim 17 wherein said thread tooth isproximally pivoted such that a protruding tooth of said thread tooth isspaced apart from said threaded outer surface.